ORAL TOXICOLOGY QC LEVEL 2

GUDID B800OLTOXQC25MLOFFGLML5

ORAL TOXICOLOGY QC LEVEL 2

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: B800OLTOXQC25MLOFFGLML5
• NIH Device Record Key: dd1c6c00-77e7-4778-811b-2f10c98bea03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORAL TOXICOLOGY QC LEVEL 2
• Version Model Number: ORAL TOX QC2 5ML OF F GLML
• Company DUNS: 092519016
• Company Name: UTAK LABORATORIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com
• Phone: 8888825522
• Email: welovecontrol@utak.com

Device Dimensions

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B800OLTOXQC25MLOFFGLML0 [Primary]
HIBCC	B800OLTOXQC25MLOFFGLML5 [Package]; Contains: B800OLTOXQC25MLOFFGLML0; Package: BOX [10 Units]; In Commercial Distribution

FDA Product Code

• LAS: Drug Specific Control Materials

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-03
• Device Publish Date: 2024-11-25

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• B800AED1V3SHCMC5 - AED LEVEL 1 V3: 2025-09-02 AED LEVEL 1 V3
• B800AED2V3SHCMC0 - AED LEVEL 2 V3: 2025-09-02 AED LEVEL 2 V3
• B800TESTOHIGHSFBRL5 - TESTOSTERONE PLUS HIGH: 2025-09-02 TESTOSTERONE PLUS HIGH
• B800TESTOLOWSFBRL5 - TESTOSTERONE PLUS LOW: 2025-09-02 TESTOSTERONE PLUS LOW